1. Field of the Invention
The subject invention relates to inflatable positioning aids for an operating room that enable a patient to be conveniently and safely positioned during surgery.
2. Description of the Prior Art
An anesthetized patient must be maintained substantially immovably in a position that enables convenient access by doctors during surgery. Additionally, the anesthetized patient must be positioned in a manner that maintains an open air passage for continuous unstressed breathing. Still further, the anesthetized patient must be positioned in a manner that will prevent long term pressure at a location that could impede blood flow or put pressure on nerves or vital structures.
Doctors and other members of a surgical team continue to use fairly crude positioning devices during surgery. For example, patients may be propped into a selected position by rolled-up sections of blankets, sheets and gauze pads. However, these fairly crude positioning devices do not provide an acceptable degree of control, and do not facilitate repositioning intraoperatively. Furthermore, a roll of fabric, or the like, may create local pressure points that would not be appreciated by the surgical team and that could impede blood flow. A restriction of blood flow during a lengthy operation can cause serious damage to limbs, and hence can require a long term regimen of post-operative physical therapy. Nerve damage or damage to other organs may be permanent.
The prior art has included several inflatable positioning aids. Most of the prior art inflatable positioning aids are very complicated structures that would be costly to manufacture. The complexities arise from having a plurality of angularly aligned internal or external panels that must be carefully secured to one another. The prior art requirement for the plurality of angularly aligned, intersecting and seamed panels adds to manufacturing and assembly costs and substantially complicates quality control inspections of the product.
The assignee of the subject invention also has rights to an inflatable positioning aid. The assignee""s inflatable positioning aid is described in copending application Ser. No. 08/733,629 which was filed on Oct. 17, 1996, and includes: a generally rectangular inflatable pillow; a tube extending into the pillow; a hand pump for directing air through the tube and into the pillow; and a valve for selectively releasing air from the pillow.
Despite the many advantages of the assignee""s prior inflatable positioning aid, the need for further improvements has been recognized by the inventors herein. For example, certain types of surgery create unique positioning requirements that may not be met appropriately by a rectangular inflatable pillow.
The subject invention relates to solutions to certain of those unique surgical positioning demands.
The subject invention is directed to inflatable positioning aids for use during a medical procedure. More particularly, the subject invention relates to inflatable positioning aids that are uniquely configured to meet demands of certain medical procedures. These inflatable positioning aids may be used with a flexible tube, a hand pump for manually inflating the positioning aid and a valve for selectively deflating the positioning aid. The inflatable positioning aid also may be used with the tube, the valve and an adaptor that can be engaged with the flexible tube and with a source of compressed air for automatic inflation of the positioning aid. Such a source of compressed air commonly is present in an operating room. Thus, the use of a source of a compressed air enables very rapid inflation and avoids the need to have a person in the operating room mechanically pump air into the inflatable positioning aid.
In all embodiments, the inflatable positioning aid is formed from a top panel and a bottom panel, at least portions of which are of substantially identical shape. Preferred embodiments of the inflatable positioning aids of the subject invention do not include end panels, side panels or internal panels that would complicate assembly and increase costs. Rather, the desired shape of the inflatable positioning aid is achieved by the careful selection of the non-inflated shapes of the top and bottom panels as described herein. In all embodiments, the inflatable positioning aid is assembled by positioning identically configured portions of the top and bottom panels in registration with one another and seaming the top and bottom panels to one another at selected locations.
At least one of the panels of the positioning aid may include a non-inflatable flap extending beyond the periphery of the inflatable portions of the positioning aid. The flap is disposed at a location on which a portion of the patient will lie. Thus, the flap functions to hold the inflatable positioning aid at a specified location during inflation, and during a medical procedure.
In one embodiment, the inflatable positioning aid defines a wedge-shape after inflation that enables the patient to be shifted from a perfectly horizontal supine position into a position where one side of a patient is elevated slightly. The inflated positioning aid to meet these requirements may be tapered from a first end defining a point or line of substantially zero cross-section to a second end defining a circle, oval or rectangle of larger cross-section. The cross-sectional difference between the first and second ends can be varied by the sizes and shapes of the panels and by the amount of air pumped into the inflatable portion of the positioning aid. Positioning aids of this type will have particularly utility in certain obstetric procedures, such as a caesarian section. In particular, during all childbirth, the uterus tends to compress the vena cava and/or the aorta, thereby impairing blood flow to the fetus (aorto-caval compression syndrome). The shifting enabled by the wedge-shape after inflation displaces the uterus and helps to avoid the compression of the vena cava and/or aorta. The inflatable positioning aid may have a non-inflatable flap extending from one end. The flap may be placed under the patient to prevent lateral shifting as the wedge-shape develops during inflation and to prevent shifting during childbirth.
The subject invention also relates to a non-rectangular inflatable positioning aid intended for supporting the face in surgical procedures that require a patient to be in a prone position. In this position, it is often difficult to conveniently position the face in a manner that will ensure that the air passages remain open. Accordingly, a generally U-shaped inflatable positioning aid may be provided. The U-shaped inflatable portion of the positioning aid may have an inflatable connecting portion and a pair of inflatable arms. The opening between the pair of inflatable arms may be dimensioned to receive the nose and mouth of the patient. In certain embodiments, the opening between the arms may be substantially T-shaped, with the central portion of the T being dimensioned and configured for receiving the nose and mouth, and with the arms of the T being dimensioned and configured for receiving the eyes of the patient, to prevent excessive pressure on the eyes. The inflatable positioning aid of this embodiment may be made of a transparent material to enable the anesthesiologist to clearly see the face and eyes when the patient is in the prone position. Ends of the arms of the inflatable positioning aid remote from the connecting portion may be joined by a sheet member or strap for ensuring that the inflatable arms remain in selected positions relative to one another, and to prevent the inflatable arms from spreading in a manner that would urge the nose and mouth downwardly against the operating table. A non-inflatable flap may further extend from ends of the arms of the inflatable positioning aid remote the connecting portion. The non-inflatable flap will carry the weight of the torso of the patient and will ensure that the inflatable positioning aid does not shift significantly relative to the patient in response to forces generated during inflation or during the medical procedure. A similar configuration may be employed for back surgery. In this embodiment, the inflatable arms diverge in a V-shape. Additionally, the non-inflatable flap may extend from the inflatable connecting portion. The space between the inflatable arms may be positioned to align with the sternum, and the non-inflatable flap may be positioned under the hips.
A third inflatable positioning aid is elongated and dimensioned to extend over substantially the entire torso of a patient. This third inflatable positioning aid includes a generally rectangular top panel and a rectangular bottom panel. The rectangular top and bottom panels may be secured to one another about the periphery of at least one panel. Additionally, an elongated central portion is rendered non-inflatable by securing the central portion of the top panel to the central portion of the bottom panel. Areas of the central portion that are not inflated may extend continuously from one longitudinal end of the rectangular inflatable positioning aid to a location near the opposed longitudinal end. This will create first and second spaced apart longitudinally extending inflatable portions. Additionally, the first and second longitudinally extending inflatable portions are connected to one another at a location in proximity to at least one of the ends. Thus, a single source of air can be employed to inflate both longitudinally extending sections of the inflatable position aid. The non-inflated central portion of this inflatable positioning aid preferably is disposed to substantially align with the spine of the patient. Thus, the spine will extend along the non-inflated groove and will not be subjected to pressure. Furthermore, this positioning aid provides two elongate inflatable supports that ensure uniform stable elevation without rocking or tilting that could occur with a single rectangular chamber under the back. An inflatable positioning aid of this type is particularly useful for heart surgery. To ensure that the inflatable positioning aid does not move, this embodiment may include first and second non-inflatable flaps extending respectively from the opposed longitudinal ends of the inflatable portion. The first non-inflatable flap may be positioned under the hips of the patient, and the second non-inflatable flap may be positioned under the head of the patient. Each flap may be a unitary extension of one panel.
A fourth inflatable positioning aid in accordance with the subject invention is intended for positioning the neck and head when the patient is in a supine position. More particularly, this inflatable positioning aid may include a generally toroidal section dimensioned and configured for supporting the back of the head and an elongate portion for positioning under the neck. The elongate portion may be substantially tangential to the toroidal portion. Additionally, the toroidal portion and the elongate portions may be separately controllable. Thus, the valve employed in this embodiment may differ from the valve employed in other embodiments in that air pressure may be selectively added to or withdrawn from either of the two separate sections of the inflatable support in accordance with the particular needs of the patient.